The Road to Recovery

Cheryl Edwards was the host of her own radio talk show. But what she wants to talk about these days is how she made it through what she says was the darkest period of her life and how there’s hope for others to do the same.

The Midwest resident was involved in a devastating car accident in 2004 that left her with a broken neck. Doctors prescribed Cheryl opioid painkillers to help manage the constant pain. In time, her body became dependent on the medication, and what once was a treatment for a medical condition turned into another one – opioid dependence.

Cheryl’s story is not out of the ordinary. In fact, the number of people dependent on or abusing opioid painkillers increased 40 percent from 2005 to 2012 (1.5 vs. 2.1 million).1 Some may think opioid dependence is a matter of poor judgment or lack of willpower.2 But in fact, it’s a chronic disease. Opioid dependence is associated with changes to the brain’s structure and function that can result from regular opioid drug use.2

“When my opioid dependence began to impact my decision making around the care of my teenage son, I realized I needed to get help,” recalls Cheryl.

That was about 10 years ago. Today, Cheryl shares her story to spread hope: “Through my personalized treatment plan, developed in conjunction with my doctor, I was able to get on the path to recovery. I want to encourage other people to seek help.”

Her individualized treatment plan included taking SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) medication in combination with counseling and psychosocial support.

Cheryl is speaking on behalf of Reckitt Benckiser Pharmaceuticals Inc. to spread awareness of this disease. She hopes to inspire others who may be struggling with opioid dependence to seek help or if you know someone who may be struggling with opioid dependence, encourage them to seek help.

Please see the Indication and Important Safety Information for SUBOXONE® Sublingual Film below. For more information about SUBOXONE® Sublingual Film, please see full Prescribing Information and Medication Guide at www.SuboxoneFilmREMS.com.

Indication

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.

Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.

Important Safety Information

Do not take SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) if you are allergic to buprenorphine or naloxone as serious negative effects, including anaphylactic shock, have been reported.

SUBOXONE® Sublingual Film can be abused in a manner similar to other opioids, legal or illicit.

SUBOXONE® Sublingual Film contains buprenorphine, an opioid that can cause physical dependence with chronic use. Physical dependence is not the same as addiction. Your doctor can tell you more about the difference between physical dependence and drug addiction. Do not stop taking SUBOXONE® Sublingual Film suddenly without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.

SUBOXONE® Sublingual Film can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other medications that act on the nervous system (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed benzodiazepines or other medications that act on the nervous system while taking SUBOXONE® Sublingual Film.

You should not drink alcohol while taking SUBOXONE® Sublingual Film, as this can lead to loss of consciousness or even death.

Death has been reported in those who are not opioid dependent.

Your doctor may monitor liver function before and during treatment.

SUBOXONE® Sublingual Film is not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment. However, SUBOXONE® Sublingual Film may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone.

Keep SUBOXONE® Sublingual Film out of the sight and reach of children. Accidental or deliberate ingestion of SUBOXONE® Sublingual Film by a child can cause severe breathing problems and death.

Do not take SUBOXONE® Sublingual Film before the effects of other opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided as you may experience withdrawal symptoms.

Injecting SUBOXONE® may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

Before taking SUBOXONE® Sublingual Film, tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant or become pregnant while taking SUBOXONE® Sublingual Film, alert your doctor immediately and you should report it using the contact information provided below.*

Neonatal withdrawal has been reported following the use of buprenorphine by the mother during pregnancy.

Before taking SUBOXONE® (buprenorphine and naloxone) Sublingual Film, talk to your doctor if you are breastfeeding or plan to breastfeed your baby. SUBOXONE® can pass into your breast milk. You and your doctor should consider the development and health benefits of breastfeeding along with your clinical need for SUBOXONE® Sublingual Film and should also consider any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how SUBOXONE® Sublingual Film affects you. Buprenorphine in SUBOXONE® Sublingual Film can cause drowsiness and slow reaction times during dose-adjustment periods.

Common side effects of SUBOXONE® Sublingual Film include nausea, vomiting, drug withdrawal syndrome, headache, sweating, numb mouth, constipation, painful tongue, redness of the mouth, intoxication (feeling lightheaded or drunk), disturbance in attention, irregular heartbeat, decrease in sleep, blurred vision, back pain, fainting, dizziness, and sleepiness.

This is not a complete list of potential adverse events associated with SUBOXONE® Sublingual Film. Please see full Prescribing Information for a complete list.

*To report negative side effects associated with taking SUBOXONE® Sublingual Film, please call 1-877-782-6966. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information about SUBOXONE® Sublingual Film or SUBOXONE® (buprenorphine and naloxone) Sublingual Tablet (CIII), please see full Prescribing Information and Medication Guide at www.SuboxoneFilmREMS.com.

References

[1] Substance Abuse and Mental Health Services Administration, Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013.

[2] World Health Organization. (2004). United Nations Office on Drugs and Crime, Joint United Nations Programme on HIV/AIDS. Position paper. Substitution maintenance therapy in the management of opioid dependence and HIV/AIDS prevention.


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